Method for removing veins

ABSTRACT

The present invention relates to devices and methods for removing veins in a venous system of a patient. One device includes an elongated shaft having a first end and a second end, the second end of the first elongated shaft sized for insertion into an incision of a patient and a cutting head associated with the second end of the elongated shaft and being movable in response to electrical energy, the cutting head being constructed to cut veins into small pieces of a patient that are exposed to the cutting head. A method of removing varicose veins is also provided. The method includes the steps of making at least one incision through the skin layer of a patient in close proximity the undesired veins, inserting a distal end of a surgical instrument having a cutting element, and advancing the cutting element end of the surgical instrument to a position adjacent to a selected vein. The method function includes the steps of energizing surgical instrument to cause the cutting element to move at a desired speed, contacting the cutting element against the undesired vein while the cutting element is moving to break up the vein into particles, and withdrawing the distal end of the surgical instrument and closing the at least one small incision.

FIELD OF THE INVENTION

The present invention relates generally to surgical apparatus andprocedures. More particularly, it relates to methods and apparatus forremoving veins, such as, varicose veins and spider veins, in a venoussystem of a patient.

BACKGROUND OF THE INVENTION

Over twenty-five percent of the population is plagued with varicoseveins and spider veins. These veins have usually lost their ability tocarry blood back to the heart and blood often accumulates in theseveins. As a result, the veins may become swollen, distorted, andprominent. This condition is usually caused by inefficient or defectiveone-way valves which prevent blood from draining back through the vein.

A number of factors can contribute to the development of varicose veinsand spider veins, including heredity, obesity, posture, standing orsitting for a long periods of time, hormonal shifts, and excessive heat.Varicose veins may cause patients to experience various symptoms, suchas, for example, aching, burning, swelling, cramping, and itching, whilemore serious complications of varicose veins can includethrombophlebitis, dermatitis, hemorrhage and ulcers. If these varicoseveins are not treated, blood clots may form in the vein, and phlebitisor inflammation of the inside lining of the vein may occur. Even absentsuch symptoms, many patients seek medical treatment of varicose andspider veins for cosmetic reasons.

Various approaches have been developed to treat varicose veins. In lesscomplicated cases, elevation of the legs and use of support hosiery maybe sufficient therapy to stop or slow the progression of the varicoseveins. Alternatively, a technique called "sclerotherapy" may be used totreat varicose veins. In this procedure, the affected veins are injectedwith a sclerosing solution, such as sodium tetradecyl sulfate orpilocainol. Approximately one injection of the solution is usuallyadministered for every inch of the affected veins, and multipleinjections may be administered during a treatment session. Thesclerosing solution causes subsequent inflammation and sclerosis of theveins. The sclerosis results in localized scarring or closure of theveins, which forces rerouting of the blood away from the affected veins.

However, patients usually have to undergo two or more sclerotherapytreatments in order to alleviate the varicose and spider veins to asatisfactory degree. Other fine reddish blood vessels may also appeararound the treated area, requiring further injections. Nevertheless, thesclerotherapy technique may not be a permanent or complete solutionsince the condition of the varicose and spider veins may reoccur withinfive years.

Sclerotherapy also has other potential complications, including browningsplotches or bruising of the skin, formation of blood clots in theveins, inflammation, adverse allergic reactions, ulceration, phlebitis,anaphylactic overdose, ischemia, skin or fat necrosis, and peripheralneuropathy. Furthermore, sclerotherapy cannot be applied to thesaphenous vein in the upper thigh region due to the risk of sclerosis ofthe deep veins. Thus, the sclerotherapy technique is often combined withan operative procedure, such as ligation of a portion of the saphenousvein.

Another technique to treat varicose veins is called stabavulsionphelbectomy with hooks. In this technique, one or more incisions aremade in the skin of a patient, and a hook is inserted into the incisionto grip or hook the veins to be removed. When the veins are grabbed, theveins are pulled though the surgical incision and severed. However, thisprocedure usually requires two surgeons to perform the procedures andtakes about 2-3 hours. In addition, this procedures usually requiresmultiple incisions in the patient in order to hook the affected veins.Furthermore, it is often difficult to completely remove the entireaffected veins using this procedure.

Varicose veins can also be removed by a procedure commonly referred toas "stripping." To remove a saphenous vein using this strippingprocedure, a large incision is made near the groin area of a patient andthe saphenous vein is separated from the femoral vein. The saphenousvein is also usually dissected near the lower portion of the leg.Multiple large incisions are made along the leg in order to sever andligate the tributary veins of the saphenous vein. A vein stripper, suchas a wire, is then inserted into the lumen of the saphenous vein. Thewire is then inserted through the saphenous vein to the groin incisionand tied to the lower end of the vein. The wire is then removed throughthe groin incision to extract the vein. After the saphenous vein iscompletely removed from the leg, the large incisions along the leg areclosed.

However, the striping procedure is usually painful and often requiresovernight hospitalization. In addition, numerous incisions are usuallyrequired to remove the saphenous vein and its branches which often leavepermanent unsightly scars along the leg of a patient. Additionally, thelarge incisions create a risk of infection to the patient and may notheal properly, especially patients who have poor circulation in theirextremities. There are also associated complications with thistechnique, such as, for example, blood loss, pain, infection, hematoma,nerve injury, and swelling.

SUMMARY OF THE INVENTION

In view of the above, the present invention provides methods andapparatus for removing undesired veins, such as, varicose and spiderveins, in a venous system of a patient. The apparatus and methods of thepresent invention provide an efficient and minimally intrusive procedureto remove the undesired veins. The undesired veins can be completelyremoved with minimal scarring and without hospitalization. The methodsand apparatus can also reduce operating time in the removal of theundesired veins, and the entire procedure can be performed by a singlesurgeon in less time than traditional procedures.

One method of removing undesired veins in accordance with the presentinvention includes the steps of making at least one incision through theskin layer of a patient in close proximity the undesired veins,inserting a distal end of a surgical instrument having a cuttingelement, and advancing the cutting element end of the surgicalinstrument to a position adjacent to a selected vein. The methodfunction includes the steps of energizing surgical instrument to causethe cutting element to move at a desired speed, contacting the cuttingelement against the undesired vein while the cutting element is movingto break up the vein into particles, and withdrawing the distal end ofthe surgical instrument and closing the at least one small incision.

One surgical apparatus for removing undesired veins in accordance withthe present invention includes an elongated shaft having a first end anda second end, the second end of the first elongated shaft sized forinsertion into an incision of a patient and a cutting head associatedwith the second end of the elongated shaft and being movable in responseto electrical energy, the cutting head being constructed to cut veinsinto small pieces of a patient that are exposed to the cutting head.

The invention, together with further attendant advantages, will best beunderstood by reference to the following detailed description of thepresently preferred embodiments of the invention, taken in conjunctionwith the accompanying drawings. It is to be understood that both theforegoing general description and the following detailed description areexemplary and explanatory and are intended to provide furtherexplanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a surgical system to removeundesired veins in a venosus system of a patient;

FIG. 1A is a fragmentary side view of the distal end of a surgicalinstrument of the surgical system of FIG. 1;

FIG. 2 is a cross-sectional view taken about line 2--2 of FIG. 1;

FIG. 3 is a diagrammatical view of undesired veins being removed fromthe legs of a patient by the surgical system of FIG. 1;

FIG. 4 shows a pattern of movement of the surgical instrument of thesurgical system of FIG. 3 to remove undesired veins;

FIG. 5 is a cross-sectional view taken about line 5--5 of FIG. 4;

FIG. 6 is a fragmentary view of the distal end of a surgical instrumentof the surgical system of FIG. 1;

FIG. 7 is a fragmentary view of another embodiment of the distal end ofa surgical instrument of the surgical system of FIG. 1;

FIG. 8 is another embodiment of a distal end of a surgical instrument ofthe surgical system of FIG. 1;

FIG. 9 is a fragmentary view of another embodiment of the distal end ofthe surgical instrument of the surgical system of FIG. 1;

FIG. 10 is a fragmentary view of another embodiment of the distal end ofthe surgical instrument of the surgical system of FIG. 1;

FIG. 11 is a side elevational view of another embodiment of a surgicalsystem to remove undesired veins in a venous system of a patent; and

FIG. 12 is a cross-sectional view taken about line 12 of FIG. 11.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before explaining the preferred embodiments in detail, it should benoted that the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description, because the illustrativeembodiments of the invention may be implemented or incorporated in otherembodiments, variations and modifications, and may be practiced orcarried out in various ways. Furthermore, unless otherwise indicated,the terms and expressions employed herein have been chosen for thepurpose of describing the preferred embodiments of the present inventionfor the convenience of the reader and are not for the purpose oflimitation.

Referring now to the drawings in detail, and particularly to FIG. 1, apreferred embodiment of a surgical system 100 to remove undesired veinsin a venous system of a patient is illustrated. The surgical system 100allows a single surgeon to remove veins from a patient more quickly thantraditional techniques. The undesired veins can be completely removedwith minimal scarring and without hospitalization. The surgical system100 can also allow two or more surgeons to remove undesired veins of apatient at the same time.

As shown in FIG. 1, the surgical system 100 generally includes a controlunit 110 and a surgical instrument 120. The control unit 110 sendselectrical signals through a cable 112 at a selected amplitude andfrequency. The electrical signals energize a motor 122 of the surgicalinstrument 120 which drives a cutting element 141 at a selected speed.The speed of the cutting element 141 of the surgical instrument 120 iscontrolled and monitored by the control unit 110.

The surgical instrument 120 of the surgical system 100 can be utilizedby a surgeon to remove undesired veins in a leg 190 of a patient. Asecond handpiece assembly (not shown) may also be connected to thecontrol unit 110 to allow a second surgeon to remove undesired veins inthe other leg 192 or another portion of the patient. It will berecognized that any suitable number of surgical instrument 120 can beattached to the control unit 110 to remove undesired veins.

As illustrated in FIG. 3, one or more small incisions 152 (one beingshown) are made through the skin layer 194 of the patient near theundesired veins. The distal end of the surgical instrument 120 isinserted through the small incision 152. Once the distal end of thesurgical instrument 120 is inserted through the incision 152, thecutting element 141 is energized at a desired speed. The cutting element141 is then placed in contact with an undesired vein 195 of the patientas shown in FIG. 3 and 5. The portion of the vein 195 that contacts thecutting element 141 is cut-up into small or tiny particles or pieces.

The particles of the undesired vein 195 are removed from the surgicalsite to a suction or vacuum source 160. After the particles are removed,the small incision 152 can be closed with steri-strips or any suitableclosure material. Although these incisions can be closed with sutures,it is considered unnecessary due to the small size of the incisions, andis also undesirable since suturing the skin can cause scarring.

Referring again to FIG. 1, the control unit 110 of the surgical system100 preferably includes a control system (not shown) integral to thecontrol unit 110, an on-off switch 112, jacks or connectors 114 and 115,a power control switch 116, and a display 118. The control unit 110sends signals to the surgical instrument 120 to control theacceleration, deceleration, and the speed of the cutting element 141 ofthe surgical instrument 120. The control unit 110 may also monitor thespeed of the cutting element 141 in order to limit the speed and thetorque of the cutting element 141 to within preselected limits foroptimum performance of the surgical instrument 120 being used. It willbe recognized that the control unit 110 may drive the cutting element141 at any suitable speed and torque.

The on-off switch 112 of the surgical system 100 controls the electricalpower to the control unit 110 to allow the surgeon to actuate thecutting element 141 of the surgical instrument 120. When the on-offswitch 112 is activated, the control unit 110 provides power to drivethe cutting element 141 of the surgical instrument 120 at a desiredspeed.

The jack 114 of the control system 110 is attached to the proximal endof the cable 112 to allow the surgical instrument 120 to be connected tothe control unit 110. The jack 115 of the control system providesanother connector to allow another cable of a surgical instrument to becoupled to the control unit 110. Although only two jacks 114 and 115 areshown, it is contemplated that any suitable number of jacks may beincorporated into the control unit 110.

The control unit 110 also has a power line 118 for insertion in anelectro-surgical unit or conventional outlet. It is contemplated thatthe control unit 110 may also be powered by a direct current (DC)source, such as a battery. The control unit 110 may be any suitablecontrol unit, such as Model No. PS3500EP™ or Dymics® KP-1 surgical drivesystem available from Smith & Nephew.

Referring still to FIG. 1, the surgical instrument 120 generallyincludes a motor drive unit or handpiece assembly 121 and a bladeassembly 140. The handpiece assembly 121 includes a motor 122, a suctionnozzle 124, a housing or an outer casing 125, a trigger mechanism 126,and a vacuum switch 128. The distal end of the handpiece assembly 121 issized and configured to receive the blade assembly 140, and the proximalend of the handpiece assembly 121 is coupled to the control unit 110 bythe cable 112. The cable 112 may include ducts or vents to allow air ora cooling fluid to be introduced into the handpiece assembly 121 to coolthe motor 122. A suitable handpiece assembly 121 may be Model Nos.7205354, 72-5355, or 72-5357, available from Smith & Nephew.

The housing 125 of the handpiece assembly 121 is adapted to isolate theoperator from the inner components of the handpiece assembly 121. Thehousing 125 is preferably substantially cylindrically shaped and isadapted to be held by a user in a conventional manner, but may be anysuitable shape or size which allows it to be grasped by the user. Whilea single or unitary component housing 125 is illustrated, the housing125 may comprise multiple parts or pieces.

The housing 125 of the handpiece assembly 121 can be constructed from aplastic, titanium, aluminum, or steel. It is also contemplated that thehousing 125 may be made from a variety of materials including otherplastics (i.e., liquid crystal polymer (LCP), nylon, or polycarbonate)or any other suitable material.

The triggering mechanism 126 of the handpiece assembly 121 allows asurgeon to activate the control unit 110 so that power may becontinuously supplied to the motor 122 of the handpiece assembly 121.The triggering mechanism 126 preferably includes a switch incorporatedin the handpiece assembly 121. It will be recognized that the triggeringmechanism 126 may alternatively include a foot activating switch 136that is detachably coupled or attached to the control unit 110 by acable or cord 138.

The suction nozzle 124 of the handpiece assembly 121 is coupled to avacuum source 160 by a hose 162. When the vacuum source 160 isactivated, the source 160 draws a vacuum through a conduit (not shown)defined through the handpiece assembly 121 and the surgical instrument120. The vacuum source 160 causes vein tissue and other fluids to bedrawn from the surgical site through the conduit of the blade assembly140 and handpiece assembly 121 into the vacuum source 160. The vacuumsource 160 can be any suitable vacuum or suction source to remove veintissue from the surgical site. It is also contemplated that the vacuumsource 160 can be a separate tool, such as, for example, a cannula, orany other suitable instrument that can be inserted in the incision toremove vein tissue.

The motor 122 of the handpiece assembly 121 is preferably disposedwithin the handpiece assembly 121. The motor 122 receives power from thecontrol unit 110 over wires (not shown) in cable 112. The motor 122preferably includes a housing 122a and a drive shaft 122b. When themotor 122 is activated, the drive shaft 122b rotates to drive thecutting element 141 of the surgical instrument 120 at a desired speed.The motor 122 is preferably a reversible rotational drive motor that canturn the drive shaft 122b in either direction or oscillate the shaft122b back and forth. It will be recognized that the motor 122 can be anysuitable device that can drive or actuate the cutting element 141 of thesurgical instrument 120.

The blade assembly 140 of the surgical instrument 120 preferablyincludes an outer stationary member 170 and a rotatable member 180. Theblade assembly 140 is preferably a disposable unit to eliminateresterilization of the portions of the assembly that enters into thepatient's body. Therefore, the blade assembly 140 is removed from thehandpiece assembly 121 after use and disposed of. The blade assembly 140may include any suitable blade from the EP-1 family from Smith & Nephew,such as, for example, the full radius 3.5 mm blade (Ref. No. 7205305),or any suitable blade from Xomed® Endoscopy Products.

The distal end of the outer stationary member 170 is sized for insertioninto an incision of the body via a puncture opening made through theskin. The outer stationary member 170 includes a fitting 172 and anelongated member 174. It is contemplated that the distal end of theblade assembly 140 may be bendable or may be articulable in variousdirections.

The fitting 172 of the outer stationary member 170 is preferably adaptedto be threaded or snapped into the distal end of the handpiece assembly121. The fitting 172 is preferably constructed from a plastic materialand has an aperture 173 extending therethrough. It is contemplated thatthe fitting 172 may be fabricated from any suitable material. The distalend of the fitting 174 is coupled or attached to the proximal end of theelongated member 174 of the outer stationary member 170.

The elongated member 174 of the outer stationary member 170 preferablyincludes an aperture 176 extending longitudinally therethrough and oneor more ports or openings 178 (one being shown). The elongated member174 preferably has a length of about 5 inches and is fabricated fromstainless steel. It is contemplated that the elongated member 174 mayhave any suitable length and can be manufactured from any suitablematerial.

The port 178 of the elongated member 174 is preferably located at ornear the distal end of the elongated member 174. As shown in FIGS. 1Aand 2, the port 178 has a generally cylindrical shape and preferablyincludes a pair of cutting edges 178a and 178b. The port 178 allows veintissue to enter into the aperture 176 so that the cutting element 141 ofthe surgical instrument 120 can sever the tissue as further describedbelow. It will be recognized that the port 178 can be any size and shapeto receive vein tissue. It is also contemplated that a guard (not shown)may also be disposed across the port 178 to limit the amount ofextraneous tissue that can enter into the port 178 to be severed.

The aperture 176 of the elongated member 174 and the aperture 173 of thefitting 172 are adapted to receive the rotatable member 180. Therotatable member 180 preferably includes a base 182 and an elongatedmember 184. The base 182 is preferably fabricated from plastic. It willbe recognized that the base 182 may be fabricated from any suitablematerial. The inner rotatable member 180 is preferably rotated atvarious speeds by the motor 122.

The distal end of the base 182 of the rotatable member 180 is coupled tothe proximal end of the elongated member 184, and the proximal end ofthe base 182 is coupled to the drive shaft 122b of the motor 122. Whenthe drive shaft 122b of the motor 122 is energized, the drive shaft 122brotates the base 182 and the elongated member 184 of the rotatablemember 180 at a desired speed.

The elongated member 184 of the rotatable member 180 preferably includesan aperture 186 extending longitudinally therethrough and a cuttingelement 141. The elongated member 184 is preferably disposed coaxiallywithin the elongated member 174 of the outer stationary member 172. Theelongated member 184 is preferably fabricated from stainless steel. Itis contemplated that the elongated member 184 may be constructed fromany suitable material.

The cutting element 141 of the elongated member 184 is disposed at ornear the distal end of the elongated member 184. Vein tissue that isexposed to the cutting element 141 through the port 178 of the outerstationary member 170 is cut by the cutting element 141 into smallpieces. The pieces are drawn through the aperture 186 of the rotatablemember 180 and through the suction nozzle 124 of the handpiece assembly121 by the use of suction applied by the vacuum source 160.

The cutting element 141 of the rotatable member 180 preferably includesone or more ports or openings 188 (one being shown) disposed in theouter surface of the elongated member 184. The port 188 has a generallycylindrical shape and preferably includes a pair of cutting edges 188aand 188b. The cutting edges 188a and 188b of the port 188 of therotatable member 180 are sharp and cooperate with sharpened edges 178aand 178b of the port 178 of the outer stationary member 170. The cuttingelement 141 may also comprise a blade, abrading burr, or ultrasonicelement.

The cutting edges 188a and 188b of the port 188 are configured forcutting vein tissue when the rotatable member 180 is rotated in eitherdirection of rotation, as selected by the surgeon. As the rotatablemember 180 rotates, the port 188 of the rotatable member 180periodically aligns with the port 178 of the outer stationary member 170to admit vein tissue. When the vein tissue enters into the ports 178 and188, the vein tissue is severed or sheared between the cutting edges188a and 188b of the rotatable member 180 and the cutting edges 178a and178b of the outer stationary member 170. The severed tissue is removedvia the aperture 186 in the rotatable member 180 and through the suctionnozzle 124 via a conduit (not shown) in the handpiece assembly 121 tothe vacuum source 160. It is also contemplated that the cutting element141 may include any suitable cutting implement and may be vibrated at ahigh rate of speed (i.e., in an ultrasonic range).

Referring now to FIGS. 6-10, a number of embodiments of the distal endof the surgical instrument 120 that can be used to remove varicose veinsare illustrated. As shown in FIG. 6, the surgical instrument preferablyincludes an outer stationary member 210 and an inner stationary member220. The outer stationary member 220 includes a fitting (not shown) andan elongated member 212.

The elongated member 212 of the outer stationary member 210 preferablyincludes an aperture 214 extending longitudinally therethrough and twoports or openings 216 and 218. The ports 216 of the elongated member 210are preferably located at or near the distal end of the elongated member210 and are arranged in a row along the side of the elongated member210. The ports 216 and 218 have a generally cylindrical shape and eachpreferably include a pair of cutting edges 230, 232, 234, and 236. Itwill be recognized that the ports 216 and 218 can be any size and shapeto receive vein tissue. A guard 220 is preferably disposed across theport 218 to limit the amount of vein tissue that can enter into the port178 to be severed.

The rotatable member 220 preferably includes a base (not shown) and anelongated member 222. The elongated member 222 of the rotatable member220 preferably includes an aperture 224 extending longitudinallytherethrough and two cutting elements 226 and 228. The elongated member222 of the rotatable member 220 is preferably disposed coaxially withinthe elongated member 212 of the outer stationary member 210. Theelongated member 222 of the rotatable member 220 is preferablyfabricated from stainless steel. It is contemplated that the elongatedmember 222 may be manufactured from any suitable material.

The cutting elements 226 and 228 of the elongated member 222 of therotatable member 220 are disposed near the distal end of the elongatedmember 222. The cutting elements 226 and 228 of the rotatable member 220preferably includes two ports or openings 240 and 242 disposed in theouter surface of the elongated member 222. The ports 240 and 242 have agenerally cylindrical shape and each preferably includes a pair ofcutting edges 244, 246, 248, and 250. The cutting edges 244, 246, 248,and 250 of the ports 240 and 242 are sharp and cooperate with sharpenededges of the ports 216 and 218 of the outer stationary member 210. Itwill be recognized that the cutting elements 226 and 228 may be a blade,abrading burr, or an ultrasonic element.

As the rotatable member 220 rotates, the ports 216 and 218 of therotatable member 220 periodically aligns with the ports 240 and 242,respectively, of the outer stationary member 210 to admit vein tissue.When the vein tissue enters into the ports, the vein tissue is severedor sheared between the cutting edges 244, 246, 248 and 250 of therotatable member 220 and the cutting edges 230, 232, 234, and 236 of theouter stationary member 210. The severed tissue is removed from thesurgical site by a vacuum source (not shown).

Referring now to FIG. 7, a distal end of another surgical instrument 300to remove undesired veins is illustrated which in many respectscorresponds in construction and function to the previously describedsurgical instrument of FIG. 6. Components of the surgical instrument 300which generally correspond to those components of the surgicalinstrument 200 of FIG. 6 are designated by like reference numerals inthe three-hundred series. As shown in FIG. 7, the surgical instrument300 includes another port 360 in the outer stationary member 310 and acorresponding port 370 of the rotatable member 320 to sever vein tissue.It will be recognized that the surgical instrument 300 may include anysuitable number of ports in the outer stationary member 310 and therotatable member 320 to cut vein tissue.

Referring now to FIG. 10, a distal end of another surgical instrument500 to remove undesired veins is illustrated which in many respectscorresponds in construction and function to the previously describedsurgical instrument 300 of FIG. 7. Components of the surgical instrument500 which generally correspond to those components of the surgicalinstrument 300 of FIG. 5 are designated by like reference numbers in thefive-hundred series. As shown in FIG. 10, the surgical instrument 500includes guards 580 and 590 that extend across ports 560 and 570 of thesurgical instrument 500, and the distal port 518 is configured without aguard.

Referring now to FIG. 8, a distal end of another the surgical instrument400 is illustrated. The surgical instrument 400 preferably includes anouter stationary member 410 and a rotatable member 420. The outerstationary member 410 includes a fitting (not shown) and an elongatedmember 412.

The elongated member 412 of the outer stationary member 410 preferablyincludes an aperture 414 extending longitudinally therethrough andopening or port 416. The port 416 of the elongated member 412 ispreferably located at or near the distal end of the elongated member412. The port 416 has a generally round shape and preferably includes acutting edge 418. It will be recognized that the port 416 can be anysize and shape to receive vein tissue. A guard 440 (see FIG. 9) may bedisposed across the port 416 to limit the amount of vein tissue that canenter into the port 416 to be severed.

The rotatable member 420 preferably includes a base (not shown) and anelongated member 422. The elongated member 422 of the rotatable member420 preferably includes an aperture 424 extending longitudinallytherethrough and a cutting element 426. The elongated member 422 of therotatable member 420 is preferably disposed coaxially within theelongated member 412 of the outer stationary member 410. The elongatedmember 412 is preferably fabricated from stainless steel. It iscontemplated that the elongated member 412 may be manufactured from anysuitable material.

The cutting element 426 of the elongated member 422 is disposed at ornear the distal end of the elongated member 422. The cutting element 426preferably includes a port or opening 428 disposed in the outer surfaceof the elongated member 422. The port 428 has a generally substantiallyround shape and a cutting edge 430 disposed around the periphery of theport 428. The cutting edge 430 of the port 428 is sharp and cooperateswith the sharpened edge of the port 416 of the outer stationary member410. It will be recognized that the cutting element 426 may comprise ablade, abrading burr, or ultrasonic element.

As the rotatable member 420 rotates, the port 428 of the rotatablemember 420 periodically aligns with the port 416 of the outer stationarymember 410 to admit vein tissue. When the vein tissue enters into theport, the vein tissue is severed or sheared between the cutting edge 430of the rotatable member 420 and the cutting edge 418 of the outerstationary member 410. The severed tissue is removed from the surgicalsite by a vacuum source (not shown).

Referring now to FIG. 11, another surgical system 700 is illustratedwhich in many respects corresponds in construction and function to thepreviously described surgical system 100 of FIG. 1. Components of thesurgical system 700 which generally correspond to those components ofthe surgical instrument 100 are designated by like reference numbers inthe seven-hundred series.

As shown in FIGS. 11 and 12, the surgical system 700 includes anirrigation assembly 800 that allows saline or other materials to beintroduced into the surgical site of the patient. The irrigationassembly 800 preferably includes and elongated member 810 and a salinebag 820. The elongated member 810 has an aperture extending therethroughto allow the saline to flow from the saline bag 820 through theelongated member 810 and into the handpiece assembly via a couplingmember 822 when a trigger member 823 is depressed. The saline flowsthrough a conduit 824 and into the surgical site. It is alsocontemplated that the coupling member 822 can be located at the distalend of the handpiece assembly or near the proximal end of the elongatedmember. It will be recognized that the tip of the instrument can bedipped into saline to introduce the saline into the surgical site or thesaline can flow through a gap formed between the outer surface of therotatable member and the inner surface of the outer stationery member.The saline can be suctioned from the surgical site when the vacuumsource is activated.

Referring now to FIGS. 3-5, the operation of the surgical system toremove undesired veins, such as, varicose and spider veins, of legs of apatient will be described. Initially, a lower extremity venous doppleris taken of the patient to reveal the incompetent valves of the veinsbetween the superficial vein system and the deeper vein system. If thereis incompetence in the greater saphenous veins going into the femoralveins and the lesser saphenous veins going into the popliteal veins, thegreater saphenous veins will be ligated and divided. During thisprocedure, the patient may undergo a general anesthetic, regionalanesthetic (i.e., spinal or epidural), or a local anesthetic.

To disconnect the saphenous vein, an incision is made in the groin areato ligate the saphenous vein at its juncture with the femoral vein. Allbranches of the saphenous vein are ligated and divided with titaniumclips and the main greater saphenous vein is ligated proximally anddistally. Alternatively, the saphenous vein can be disconnected from thedeep veins at a lower point along the leg, such as behind the knee atthe lesser saphenouspopliteal junction. This alternative technique maybe advisable in circumstances in which treatment of various veins isonly necessary in the lower leg.

When the saphenous vein is disconnected from the femoral vein, the bloodfrom the deep veins will be prevented from flowing backing into thesaphenous vein, eliminating the primary cause of the varicose veins.While blood can still enter the saphenous vein through the numeroustributary veins, the subsequent permanent closure of the saphenous veinwill effectively prevent this occurrence. Once the saphenous vein isdisconnected from the femoral vein, the varicose and/or spider veins canbe treated. It will also be recognized that the saphenous vein may nothave to be disconnected.

To remove the undesired veins, the patient is placed in a trendelenburgposition, i.e., feet up, and the incision site is prepared. After properpreparation of the incision site, a surgeon makes a small incision 152through the skin layer and subcutaneous tissue of the patient. Theincision is approximately 2-3 mm and only needs to be large enough topermit the distal end of the surgical instrument 120 pass therethrough.The incision 152 may be made by a blade, such as a mall surgicalscalpel, such as a Number 67 scalpel blade. The incision 152 ispreferably made near the center of the undesired veins to reach the mostveins. It should be apparent that the selection of the incision 152 isfor exemplary purposes only and the incision may be made at any suitablelocation.

After completing the incision 152, the distal end of the surgicalinstrument 120 is inserted through the incision 152 made at the skinwith the motor 122 of the handpiece assembly 121. It is alsocontemplated that the distal end of the surgical instrument 120 may havea sharp point that enables it to be inserted through the skin layerwithout having to first make an incision. For example, the surgicalinstrument 120 may have a retractable scalpel blade.

Once the distal end of the surgical instrument 120 is passed through theincision, the surgeon then activates the switch 128 to cause vacuumsuction. The distal end of the surgical instrument 120 is placed on theundesired vein in order to move the vein away from the skin and toremove as much vein tissue with the vacuum suction. The distal end ofthe surgical instrument 120 is then guided underneath or on the side ofthe vein to be removed. The surgeon then activates the switch 126 toactuate the cutting element 141 of the surgical instrument 120 at apredetermined speed.

The surgeon can control rotational speed and direction (eitherunidirectional or oscillatory) using the switch 126 on the handpieceassembly 121 or the foot switch 136. The cutting element 141 can rotateover a wide range of speeds, for example, approximately 500-2000 rpm,and preferably in the range of 1200-1800 rpm. Saline can also beintroduced into the surgical site.

The vacuum suction 160 draws the vein tissue to be cut into the port 178of the outer stationary member 170. As the vein is drawn into the port178, the vein is severed by the cutting element 141 of the rotary member180 and cut into small particles.

As shown in FIG. 4, the surgeon can move the surgical instrument 120back and forth under the skin and pushing it in and out in a fan-like orcircular fashion as permitted to progressively cut away the vein. Theamount of cutting varies with the speed of the rotatable member 180, theamount of pressure applied by the surgeon, the sharpness of the cuttingedges, and the number and size of the ports on the outer stationarymember 170.

After the vein is removed, the incision is closed by conventionaltechniques, such as, with steri-strips. While suturing of the incisionis also possible, it is considered unnecessary due to the small size ofthe incision, and is also undesirable since suturing the skin can causescarring. This procedure can then be repeated at another location.

Once the undesired veins are removed, a stocking can be rolled up on thepatient's leg and a convatec duoderm elastaplast type stocking can beplaced from just proximal to the toes to the upper thigh in order forcompression to take place.

The apparatus and methods of the present invention allow various veinsto be removed with minimal scaring and without hospitalization.Moreover, the procedure can be performed on an outpatient basis withoutany of the usual complications of conventional surgical procedures. Theprocedure can be performed in a short period of time to avoid physicianfatigue, minimize anesthesia time for the patient, and increase thenumber of procedures possible with a given operating room facility.

Although the present invention has been described in detail by way ofillustration and example, it should be understood that a wide range ofchanges and modifications can be made to the preferred embodimentsdescribed above without departing in any way from the scope and spiritof the invention. Thus, the described embodiments are to be consideredin all respects only as illustrative and not restrictive, and the scopeof the invention is, therefore, indicated by the appended claims ratherthan the foregoing description. All changes that come within the meaningand range of equivalency of the claims are to be embraced within theirscope.

What is claimed is:
 1. A method for removing undesired veins from a bodyof a patient comprising the steps of:making at least one incisionthrough the skin layer of a patient in close proximity to the undesiredveins; inserting a distal end of a surgical instrument through the atleast one incision, the distal end of the surgical instrument having acutting element; advancing the cutting element of the surgicalinstrument to a position adjacent to a selected vein; energizing thesurgical instrument to cause the cutting element to move at a desiredspeed; contacting the cutting element against the undesired vein whilethe cutting element is moving to break up the vein into particles;withdrawing the distal end of the surgical instrument; and closing theat least one small incision.
 2. The method of claim 1 further comprisingthe step of applying suction to remove the particles.
 3. The method ofclaim 1 further comprising the steps of:making a second incision in theskin of a patient; and ligating the junction between the saphenous veinand deep veins of the patient's leg.
 4. The method of claim 1 furthercomprising the step of moving the distal end of the surgical instrumentin and out of the incision in a circular configuration.
 5. The method ofclaim 1 wherein at least one incision is substantially centered over agroup of undesired veins.
 6. The method of claim 1 further comprisingthe step of repeating said making, inserting, advancing, energizing,contacting, and closing steps.
 7. The method of claim 1 wherein thecutting element is rotatable about a first axis.
 8. The method of claim1 further comprising the step of introducing saline into the patient.